OSE Immunotherapeutics Presented New Translational Data on Tedopi® and Preclinical Data on PD-1/IL-7 Bifunctional Program BiCKI®-IL-7 Data presented at the 36th Annual Society for Immunotherapy of Cancer (SITC) Meeting

NANTES, France I November 16, 2021 I OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) presented new clinical and translational data on Tedopi® (neoepitope-based cancer vaccine) in non-small cell lung cancer and the latest data from BiCKI®-IL-7 (bifunctional therapy targeting PD-1 and IL-7) preclinical programs at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting in Washington D.C. (and virtually) held on November 10 – 14, 2021.

Nicolas Poirier, Chief Scientific Officer of OSE Immunotherapeutics, comments: “We are happy to share our latest data demonstrating the advancements we made with our clinical and preclinical immuno-oncology products: the neoepitope-based vaccine Tedopi® and BiCKI®-IL-7, the novel bispecific therapy combining anti-PD1 and IL-7 cytokine. Both products aim at addressing the high unmet clinical needs of patients suffering from immune escape following checkpoint inhibitor treatments. This progress further reinforces the Company’s leading position in immuno-oncology by pushing forward these high potential promising assets.”

The poster entitled: “Combined exploratory immunophenotyping and transcriptomic tumor analysis in patients treated with OSE2101 (Tedopi®) vaccine in HLA-A2+ advanced non-small cell lung cancer (NSCLC) from the ATALANTE-1 trial” included clinical data from a translational analysis performed from HLA-A2+ patients treated with Tedopi® in the Atalante-1 Phase 3 clinical trial. Available tumor biopsies at initial diagnosis were analyzed to determine the expression of the tumor-associated antigens (TAAs) and to identify other tumor factors associated with long-term survival. This translational analysis showed :

  • A high/high Immunoscore® associated with high CD8 T-cell tumor infiltration, and a higher proportion of CD8 cells interacting with PD-L1 cells in a patient with a partial response;
  • Transcriptomic data have shown an activated macrophage pathway. High IFN-ɣ and expanded immune gene signatures scores were observed in long-term surviving patients with secondary resistance to immune checkpoint blockade.

The Phase 3 clinical trial Atalante-1 demonstrated a favorable benefit/risk ratio of Tedopi® versus standard of care (SoC) docetaxel or pemetrexed in advanced HLA-A2+ NSCLC patients with secondary resistance to immune checkpoint inhibitors (data presented at the 2021 European Society for Medical Oncology Congress).

The poster entitled: “Long-term anti-tumor preclinical efficacy of an optimized anti-PD-1/IL-7 bifunctional antibody sustaining activation of progenitor stem-like CD8 TILs and disarming Treg suppressive activity” has described a monotherapy with BiCKI®-IL-7, an anti-PD1/IL-7 bifunctional monoclonal antibody, that induces long-term survival, proliferation and responses without signs of exhaustion of T cells as well as robust in vivo anti-tumor memory response in different preclinical models.

Interestingly, targeting IL-7 on PD1+ tumor-specific T cells has shown to have a unique property in selectively inducing the proliferation and survival of TCF1+ (T Cell Factor 1) stem-like CD8 T cells in vitro in human T-cell exhaustion model and in vivo in mouse tumor model, avoiding exhaustion of stem tumor-reactive T cells and hence providing long-term anti-tumor memory.

TCF1+ PD1+ CD8 T cells, which express high level of IL-7R, have been broadly described these last years as T cells with potent stem-like properties promoting tumor control in response to vaccination or checkpoint blockade immunotherapy (Siddiqui I. et al. Immunity 2019; Zhao Xudong et al. Nature Review Immunology 2021).

Poster #366   “Combined exploratory immunophenotyping and transcriptomic tumor analysis in patients treated with OSE2101 vaccine in HLA-A2+ advanced non-small cell lung cancer (NSCLC) from the ATALANTE-1 trial”
    Category: Clinical Trials Completed
Poster #794   “Long-term anti-tumor preclinical efficacy of an optimized anti PD-1/IL-7 bifunctional antibody sustaining activation of progenitor stem-like CD8 TILs and disarming Treg suppressive activity”
    Category: Immuno-conjugates and chimeric molecules

ABOUT OSE Immunotherapeutics

OSE Immunotherapeutics is an integrated biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company’s immunology research and development platform is focused on three areas: T-cell-based vaccination, Immuno-Oncology (focus on myeloid targets), Auto-immunity & Inflammation. Its balanced first-in-class clinical and preclinical portfolio has a diversified risk profile:
Vaccine platform

  • Tedopi® (innovative combination of neoepitopes): the company’s most advanced product; positive results for the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients after secondary resistance to checkpoint inhibitors.
    In Phase 2 in pancreatic cancer (TEDOPaM), sponsor GERCOR.
    In Phase 2 in ovary cancer, in combination with pembrolizumab (TEDOVA), sponsor ARCAGY-GINECO.
    In Phase 2 in non-small cell lung cancer in combination with nivolumab, sponsor Italian foundation FoRT.
  • CoVepiT: a prophylactic second-generation vaccine against COVID-19, developed using SARS-CoV-2 optimized epitopes against multi variants. Positive preclinical and human ex vivo results. Voluntary and temporary Phase 1 enrollment suspension on-going (July 2021).

Immuno-oncology platform

  • BI 765063 (OSE-172, anti-SIRPα mAb on CD47/ SIRPα pathway): developed in partnership with Boehringer Ingelheim in advanced solid tumors; positive Phase 1 dose escalation results of BI 765063 in monotherapy or in combination with ezabenlimab (PD-1 antagonist); Expansion Phase 1 open for screening.
  • CLEC-1 (novel myeloid checkpoint target): identification of mAb antagonists of CLEC-1 blocking the “Don’t Eat Me” signal that increase both tumor cell phagocytosis by macrophages and antigen capture by dendritic cells.
  • BiCKI®: bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) combined with new immunotherapy targets; 2nd generation of PD-(L)1 inhibitors to increase antitumor efficacity.

Auto-immunity and inflammation platform

  • FR104 (anti-CD28 monoclonal antibody): Licensing partnership agreement with Veloxis in the organ transplant market; ongoing Phase 1/2 in renal transplant (sponsored by the Nantes University Hospital); Phase 2-ready asset in an autoimmune disease indication.
  • OSE-127/S95011 (humanized monoclonal antibody targeting IL-7 receptor): developed in partnership with Servier; positive Phase 1 results; in Phase 2 in ulcerative colitis (OSE sponsor) and an independent Phase 2a ongoing in Sjögren’s syndrome (Servier sponsor).
  • OSE-230 (ChemR23 agonist mAb): first-in-class therapeutic agent with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity.

For more information:https://ose-immuno.com/en/

SOURCE: OSE Immunotherapeutics

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